Hycor Biomedical | Cleanroom Cooling System
Hycor Biomedical is a medical device manufacturer and supplier specializing in allergy testing, autoimmune, and in-vitro diagnostic products. Hycor Biomedical’s manufacturing facility in Garden Grove, California produces highly-sensitive medical equipment used in clinical laboratories, hospitals, and doctor’s offices around the globe. Complete with multiple pharmaceutical clean-rooms, the facility holds strict environmental quality controls for both regulatory and patient safety reasons.
Our consulting engineering team at California Energy Designs provided Air-Quality Control System (AQCS) design services for the cleanroom cooling system, supplying over 45-tons of cooling, in eight distinct zones, for the Garden Grove facility’s pharmaceutical clean-rooms. While every Air Quality Control project requires strict adherence to the precise environmental needs of a facility—from temperature & humidity requirements to filtration banks and particulate removal systems—however, when dealing with allergenic testing products and in-vitro devices, the stringent requirements hold even greater weight.
The FDA publishes official guidance on cleanroom design, including air control, clean air separation, and air filtration requirements, partially based on Current Good Manufacturing Practice (CGMP) regulations. Such regulations include both required and recommended standards. These requirements include monitoring systems for environmental conditions, equipment to control humidity, dust, air pressure, temperature and microorganisms, and air filtration systems to prevent contamination, remove airborne particulates, and ensure a stringently aseptic environment.
Diagnostic equipment, particularly for medical diagnostics, is highly sensitive to environmental conditions, and Hycor Biomedical’s manufacturing facility produces such devices for the allergen, autoimmune, and in-vitro industry-segments, each of which is extremely sensitive to particulate matter, independently. In approaching the cooling system design, each of the eight separate air zones were engineered to specific facility clean air requirements with an extraordinary level of precision.
For more information on cleanroom airflow systems, filtration, and FDA requirements please refer to this general overview and the official FDA published guidance. Photos of Hycor Biomedical’s Garden Grove manufacturing facility are not publically available, all imagery utilized is stock licensed material.